EUCTR2011-005675-16-IT进行中（未招募）不适用
A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two FBS0701 Doses in the Treatment of Chronic Iron Overload Requiring Chelation Therapy - FBS0701 in the treatment of chronic iron overload
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. The patient must be willing to sign the informed consent form approved and must be able to do so. 2. Age: 18-60 years at screening 3. Patients who, until then, had more than 20 transfusions and iron overload are affected by transfusion-dependent, requiring chronic treatment with a chelating agent of iron. Please note that Patients with sickle cell disease who carry out periodic exchange transfusions, and patients with iron overload with thalassemia intermedia are eligible to participate in the study. 4. Agree to discontinue any iron chelation therapy in progress, for a minimum period of one to five days before the first dose of FBS0701, for 24 weeks of study days and 1 week after the last dose, for a total of about 26 weeks. 5. Agree to stay on an empty stomach two hours before and one hour after each dose. 6. Present a serum ferritin> 500 ng / ml at screening. 7. The concentration of iron in the liver, the extent of reference (from Day -14 to Day -7) must be = 5 mg of iron per g (dry weight equivalent) determined by MRI FerriScan. 8. The average concentrations of the three previous pre-transfusion hemoglobin must be = 7.5 g / dl. 9. The patient agrees to use a contraceptive method approved by the time of screening up to 28 days after the last dose of study medication. Among the accepted methods of contraception are cited as follows: condoms, birth control pills approved, patches, implants or injections, vaginal diaphragm with spermicide, intrauterine device (IUD) and / or surgical sterilization (vasectomy or tubal ligation at least six months prior to administration of doses). Patients who practice abstinence must agree to use an approved method of contraception, if they become sexually active during the course of the study. All women will be fertile again subjected to pregnancy tests every month during the screening and for the duration of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Following clinical evaluation, physical examinations or investigations carried out during the screening, the principal investigator considered the patient unsuitable for participation in the study. 2. Non-elective hospitalization in the last 30 days before the exams reference. 3. Evidence of the presence of oral diseases, cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, immunological, bone marrow or skin, clinically relevant, by the principal investigator confirmed that the administration of FBS0701 inadvisable. 4. Iron overload due to causes other than siderosis transfusion-dependent. 5. Found significant renal insufficiency, eg. serum creatinine greater than 1.5 the upper limit of normal, proteinuria greater than 1 g per day or calculated creatinine clearance less than 40 ml / minute. 6. Severe iron overload, including: a. Of MRI T2 *> 10 ms; b. liver iron concentration determined by R2 MRI of> 30 mg / g liver (dry weight). 7. Known sensitivity to magnesium stearate, sodium croscarmellose, or a FBS0701. 8. Platelet count less than 100,000 and / or absolute neutrophil count less than 1500/mm3 at the screening. 9. Poor venous access that precludes the possibility of blood draws for laboratory tests required for safety assessment 10. ALT at screening = 200 IU / L. 11. Use of any investigational drug within 30 days preceding the baseline procedures. 12. Pregnant or breastfeeding
研究者
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